Status:
COMPLETED
Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Brief Summary
This research study is being conducted to help understand how the symptoms during treatment for acute myeloid leukemia (AML) may be affected by metabolism and how best to study this association. Sympt...
Detailed Description
This is a prospective, longitudinal, observational exploratory study. Ten participants will be enrolled and will complete baseline and week 4 blood sample collections. Symptom questionnaires will be c...
Eligibility Criteria
Inclusion
- The Cantor Center CRC will attend weekly protocol meetings in the DFCI adult leukemia center to identify eligible patients and will confirm eligibility by reviewing the electronic health record and, if needed, contacting the treating physician. Subjects enrolled in clinical trials or other studies requiring extra blood samples and/or completion of questionnaires will be discussed with their oncology care team and/or investigators of the other study teams to ensure avoidance of excess subject burden. Only subjects deemed appropriate for enrollment without adding excess burden will be approached about this study.
- Adult (18+ years old)
- New diagnosis of acute myeloid leukemia (AML)
- Admitted to the DFCI Inpatient Hospital in the BWH for intensive induction chemotherapy (e.g., 7+3 regimen)
- Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) ≤ 3 OR Karnofsky Performance Status (KPS) ≥ 50
- Ability to comprehend and speak English
- Ability to provide informed consent
Exclusion
- Cognitive or psychiatric conditions prohibiting study consent or participation
- Multiple primary cancers
- A treating clinician reports that the subject is inappropriate for the study or that the study presents excess subject burden
Key Trial Info
Start Date :
July 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04908852
Start Date
July 26 2021
End Date
February 23 2023
Last Update
April 5 2023
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115